Quality Assurance Consultant

Quality Assurance Consultant Position

The Quality Assurance position is a consultant position with options to become a permanent full-time employee that provides oversight of Quality (QA & QC) functions at Marin Biologic Laboratories (Marin Bio). The Quality Assurance (QA) person works onsite at the Marin Bio facility located in Novato, CA. The position requires the QA to be an exceptionally organized and methodical professional who has the experience necessary to oversee GxP testing and documentation to meet the requirements of FDA’s 21 CFR Part 58 and 21 CFR Part 210, 211, and 600 regulations. The QA oversees the Quality Management System and fosters a culture in which all employees are actively engaged in quality by design processes.

Marin Bio is a contract research organization working with the pharmaceutical and biotechnology industries. Our scientists develop and validate drug release assays, perform drug stability studies and research surrounding this effort. The scientific areas include molecular and cellular biology, immunology and biochemistry. Marin Bio is a small company that strives for the best quality in our work and communications with our clients, as well as a balanced life for our staff. The company has been operating for over 30 years, our website is: marinbio.com.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Ownership and maintenance of Marin Bio Laboratories’ Quality Manual.

Oversee the development and maintenance of Marin Bio Laboratories’ Quality Management System (Management Review, Change Control, CAPA, Deviations, Lab Investigations, Complaints, Internal Audits, Training, and Vendor Management) in accordance with regulatory requirements and expectations.

This includes:

Oversight of the Document Control system including documentation and tracking of requests, approvals and

implementation

Oversight of master documents and records, training records, audit files and raw data

Review and approval of applicable GxP documentation

Ensure data integrity compliance, specifically with 21 CFR Part 11 and ALCOA+

Ensure QA and QC operations required to assess, evaluate, and review operations on the research floor and observe real-time observation of activities. Review all test records and raw data to assure no errors or omissions have occurred. Approve or reject GMP test data according to established specifications. Also, identify, investigate, and resolve issues including proper and timely documentation.

Review and approval of Quality Agreements, ensuring Marin Bio Laboratory operations meet client requirements.

Establish appropriate metrics for the tracking and trending of Marin Bio Laboratories’ QMS.

Lead customer audits, regulatory inspections, and internal audits

Ensure compliance with validation and calibration programs.

Utilize quality tools and techniques to perform and document root cause analysis investigations, evaluate and resolve quality issues, and support continuous improvement. Perform training and support that covers policies, procedures and core processes

Perform other duties as directed, developed or assigned.

Staying up to date with regulatory requirements and applying it to Marin Bio.

Reports directly to the CEO

QUALIFICATION REQUIREMENTS

Education and/or Experience: Bachelors degree in Chemistry, Biochemistry, Molecular or Cell Biology preferred or equivalent work. Minimum 5+ years in a Quality position. Experience managing Deviation, CAPA, Change Control, Audit, Scientific Review, and Quality Control documents. GMP/GDP training and experience. Experience with Regulatory Inspections. Coach Subject Matter Experts.

Language Skills: Strong technical writing/editing skills. Read, write, and verbally communicate effectively and professionally with other business departments, clients and vendors. Ability to diplomatically deal with difficult situations and people, while exhibiting a consistent level of professionalism.

Technical Skills: Knowledge of GMP, GLP and FDA and EU standards and relevant guidance. Good Documentation Practices (GDP) and reporting skills. Deep knowledge of quality assurance terminology, methods and tools. Knowledge of IQ/OQ/PQ protocols, equipment validation and Continuous Improvement techniques. Familiarity with basic analytical data analysis and QA/ QC tools and methods.

Reasoning Ability: Excellent problem-solving, analytical and decision-making skills. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, report or schedule form.

Other Skills & Abilities: Strong organizational skills. Able to work with little or no supervision. Ability to work independently and as part of a team. Strong attention to detail and timelines. Ability to prioritize and manage several projects and activities simultaneously. Microsoft Office skills. Demonstrates positive attitude, strong work ethic, and self-motivation. Fast learner, able to react quickly in a fast-paced environment. Customer Service / Quality Driven.